Effects of Sleep Body Temperature on Body Composition

This will be a crossover controlled trial designed to recruit 40 participants, who will be divided into two groups of 20 subjects each. The participants will be randomly assigned to either Group A or Group B. Group A will receive the sleep electric blanket intervention for a period of 7 days, while Group B will serve as the control group without any additional intervention. After the intervention period, there will be a washout period of 7 days to ensure that any effects of the intervention have subsided before the crossover.

Following the washout period, the groups will switch roles: Group B will then receive the sleep electric blanket intervention, and Group A will become the control group. This second phase will also last for 7 days, preceded and followed by the same assessment procedures as the initial phase. This design will allow for a comparison of the intervention's effects against a control period within the same group of participants, enhancing the study's internal validity.

Study Overview

• Status: Not yet recruiting
• Conditions: Heart Rate; Aldosterone Disorder; Blood Pressure Check (Hypertension Screening)
• Intervention / Treatment: Device: Electric Blanket

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fangfang Zeng; Phone Number: +86 13822285635; Email: zengffjnu@126.com
• Study Contact Backup: Name: Jiamin Qiu; Phone Number: +86 178196663352; Email: adniminday@163.com

Study Locations

• China
  • Select a State
    • Guangzhou, Select a State, China, 510632
      • Jinan University Guangzhou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

- Participants aged 18-30 years, inclusive of both male and female genders.

Exclusion Criteria:

• Individuals suffering from serious diseases such as heart, liver, kidney, brain, hematopoietic, immune, thyroid, malignant tumors, etc.;
• Those with familial hereditary hypertension (both parents are hypertensive) or those diagnosed with hypertension;
• Individuals with cognitive or mental impairments that prevent the completion of the questionnaire;
• Persons with physical disabilities that hinder normal walking;
• Persons who have experienced a weight change of >3.0 kg within 1 month or >10 kg within 6 months prior to screening (as per the study in Nutrients. 2020 Oct 21;12(10):3221);
• Individuals required to take antibiotics from one week before the trial starts until its conclusion;
• Those with habitual diarrhea or who have experienced diarrhea from one week before the trial starts until its end;
• Subjects who have participated in other ambient temperature-related trials within the last 6 months;
• Individuals with extreme sleep schedules (i.e., not falling asleep between 21:00 and 2:00 a.m. the following morning, or waking up before 5:00 a.m.);
• Those with sleep latency (the time it takes to fall asleep after going to bed) greater than one hour;
• Pittsburgh Sleep Quality Index (PSQI) scores greater than 16;
• Participants who do not sign the informed consent form or are deemed unsuitable by the investigator for any other reason.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mild-heat group; Participants will be randomized into groups A and B. When the subject's group cohort undergoes the intervention phase (as opposed to the control phase), they will receive a 7-day, 8-hour intervention with an electric blanket set at +5±1°C above room temperature.	Device: Electric Blanket; Participants were randomized to groups A and B. When the subject's group cohort went through the intervention phase (instead of the control phase), they received a 7-day, 8-hour intervention with an electric blanket +5±1°C above room temperature.
No Intervention: Non-mild-heat group; Participants will be randomized into groups A and B. There will be no additional sleep temperature intervention while the group is in the control period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure	Including systolic blood pressure (SBP) and diastolic blood pressure (DBP), Includes office blood pressure, home blood pressure and ambulatory blood pressure.	1month

Collaborators and Investigators

• Sponsor: Jinan University Guangzhou

Study record dates

Study Major Dates

• Study Start (Estimated): October 20, 2024
• Primary Completion (Estimated): January 30, 2025
• Study Completion (Estimated): January 30, 2025

Study Registration Dates

• First Submitted: October 15, 2024
• First Submitted That Met QC Criteria: October 17, 2024
• First Posted (Actual): October 18, 2024

Study Record Updates

• Last Update Posted (Actual): October 18, 2024
• Last Update Submitted That Met QC Criteria: October 17, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: JNUKY-2023-0126

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The experiment will be made public upon completion with the publication of the related paper, sharing: contact the researcher for a copy.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No